S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   5489
 
                        2021-2022 Regular Sessions
 
                             I N  S E N A T E
 
                               March 9, 2021
                                ___________
 
 Introduced  by  Sen.  BROUK  -- read twice and ordered printed, and when
   printed to be committed to the Committee on Higher Education
 
 AN ACT to amend the education law, in relation to  the  registration  of
   nonresident  pharmacies,  manufacturers,  wholesalers  and outsourcing
   facilities that deliver prescription drugs  to  other  establishments,
   authorized prescribers and patients residing in this state
 
   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. Subdivision 2 of section 6808-b of the  education  law,  as
 amended  by  chapter  567  of  the  laws  of 2002, is amended to read as
 follows:
   2. Registration. (A) All nonresident establishments that  ship,  mail,
 or  deliver prescription drugs and/or devices to other registered estab-
 lishments, authorized prescribers, and/or patients into this state shall
 be registered with the department; except that such  registration  shall
 not  apply  to  intra-company transfers between any division, affiliate,
 subsidiaries, parent or other entities under complete  common  ownership
 and  control.  The  provisions of this subdivision shall apply solely to
 nonresident establishments and shall not affect any other  provision  of
 this article.
   (B)  NOTWITHSTANDING  THE  PROVISIONS OF THIS ARTICLE, AN UNREGISTERED
 NONRESIDENT ESTABLISHMENT MAY SHIP, MAIL, OR DELIVER PRESCRIPTION  DRUGS
 AND/OR  DEVICES TO REGISTERED ESTABLISHMENTS IN THIS STATE IN CASES OF A
 SPECIFIC PATIENT NEED OR A DECLARED PUBLIC  HEALTH  EMERGENCY,  PROVIDED
 THAT:
   (I) THE UNLICENSED ESTABLISHMENT IS APPROPRIATELY LICENSED IN ITS HOME
 STATE,  AND  DOCUMENTATION OF THE LICENSE VERIFICATION CAN BE MAINTAINED
 BY THE RESIDENT ESTABLISHMENT;
   (II) IN CASES OF SPECIFIC PATIENT NEED, THE  REGISTERED  ESTABLISHMENT
 SHALL MAINTAIN DOCUMENTATION THAT THE TRANSFER IS FOR SUCH PURPOSE;

  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD09095-01-1
              

 S. 5489                             2
 
   (III)  THE  RESIDENT  ESTABLISHMENT  COMPLIES  WITH ALL RECORD-KEEPING
 REQUIREMENTS FOR EACH DRUG OR DEVICE  RECEIVED  FROM  ANY  PHARMACY  NOT
 REGISTERED BY THE DEPARTMENT;
   (IV)  ALL  DOCUMENTATION  AND  RECORDS  ARE  RETAINED  AND ARE READILY
 RETRIEVABLE BY THE RESIDENT ESTABLISHMENT FOR A PERIOD OF  THREE  YEARS;
 AND
   (V)  THE PRESCRIPTION DRUG OR DEVICE WAS MANUFACTURED BY AN AUTHORIZED
 FDA REGISTERED DRUG MANUFACTURER.
   (C) FOR PURPOSES OF PARAGRAPH (B) OF THIS SUBDIVISION, DOCUMENTS SHALL
 BE DEEMED TO BE MAINTAINED, RETAINED,  OR  READILY  RETRIEVABLE  BY  THE
 RESIDENT  ESTABLISHMENT  IF  THEY ARE AVAILABLE WITHIN SEVENTY-TWO HOURS
 FROM A THIRD-PARTY WHO ARRANGED OR FACILITATED THE TRANSACTION.
   (D) FOR PURPOSES  OF  PARAGRAPH  (B)  OF  THIS  SUBDIVISION  "SPECIFIC
 PATIENT  NEED"  MEANS  THE  TRANSFER  OF  A PRODUCT FROM ONE PHARMACY TO
 ANOTHER TO FILL A PRESCRIPTION FOR AN IDENTIFIED PATIENT. SUCH TERM DOES
 NOT INCLUDE THE TRANSFER OF A PRODUCT FROM ONE PHARMACY TO  ANOTHER  FOR
 THE  PURPOSE  OF  INCREASING  OR REPLENISHING STOCK IN ANTICIPATION OF A
 POTENTIAL NEED.
   § 2. This act shall take effect immediately.